Trial Outcomes & Findings for Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation (NCT NCT03068611)
NCT ID: NCT03068611
Last Updated: 2019-10-07
Results Overview
Self-report abstinence from smoking
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
1 month after enrollment
Results posted on
2019-10-07
Participant Flow
Study recruitment was conducted online over 7 weeks (May to July, 2017). Only newly registered users of BecomeAnEX.org were recruited.
Participant milestones
| Measure |
Standard Web-based Smoking Cessation
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
Alcohol-focused Web-Based Smoking Cessation
A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.
Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
58
|
|
Overall Study
COMPLETED
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
31
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
Baseline characteristics by cohort
| Measure |
Standard Web-based Smoking Cessation
n=61 Participants
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
Alcohol-focused Web-Based Smoking Cessation
n=58 Participants
A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.
Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
38.0 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after enrollmentSelf-report abstinence from smoking
Outcome measures
| Measure |
Standard Web-based Smoking Cessation
n=61 Participants
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
Alcohol-focused Web-Based Smoking Cessation
n=58 Participants
A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.
Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
|---|---|---|
|
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 6 months after enrollmentSelf-report abstinence from smoking
Outcome measures
| Measure |
Standard Web-based Smoking Cessation
n=61 Participants
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
Alcohol-focused Web-Based Smoking Cessation
n=58 Participants
A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.
Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
|---|---|---|
|
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months
|
9 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 1 month after enrollmentSelf reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
Outcome measures
| Measure |
Standard Web-based Smoking Cessation
n=45 Participants
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
Alcohol-focused Web-Based Smoking Cessation
n=40 Participants
A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.
Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
|---|---|---|
|
Number of Heavy Drinking Days at 1 Month
|
2.9 Days
Standard Deviation 4.7
|
4.4 Days
Standard Deviation 6.3
|
PRIMARY outcome
Timeframe: 6 months after enrollmentSelf reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
Outcome measures
| Measure |
Standard Web-based Smoking Cessation
n=30 Participants
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
Alcohol-focused Web-Based Smoking Cessation
n=33 Participants
A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.
Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
|
|---|---|---|
|
Number of Heavy Drinking Days at 6 Months
|
2.6 Days
Standard Deviation 3.5
|
3.8 Days
Standard Deviation 6.7
|
Adverse Events
Standard Web-based Smoking Cessation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcohol-focused Web-Based Smoking Cessation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place